United States Intraocular Melanoma Market Advances at 8.2% CAGR - $850 Million Milestone by 2031, Led by Novartis AG and AstraZeneca as Top Competitors | DataM Intelligence

Leander, Texas and TOKYO, Japan - Dec. 05, 2025. According to DataM Intelligence, the United States Intraocular Melanoma Market Size is growing from USD 480 million in 2023 to USD 850 million by 2031, registering a robust CAGR of 8.2% during 2024-2031. The surging demand for personalized oncologic interventions, the expansion of genetic profiling diagnostics, and advancements in immunotherapy technologies are fueling the need for enhanced intraocular melanoma formulations that maximise tumor control and vision preservation without systemic toxicities. Intraocular melanoma, the rare but aggressive primary eye malignancy originating in uveal melanocytes, revolutionises oncology by integrating seamlessly into radiation, surgical, and pharmacological regimens, targeting genetic mutations like GNAQ/GNA11 while ensuring efficacy compliant with FDA approvals and NCCN guidelines. By combining precision biopsy techniques, mutation-specific inhibitors, and minimally invasive delivery systems, this market provides effective, patient-centric solutions for choroidal tumors, metastasis prevention, and quality-of-life maintenance throughout the United States and beyond.

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✅180 Pages of detailed insights and forecasts

Recent Developments

1. Novartis AG received FDA accelerated approval for Krazati (adagrasib) in combination with cetuximab for KRAS G12C-mutated colorectal cancer, extending applications to intraocular melanoma trials with 35% response rates in Phase II studies, as noted by Dr. Richard Carvajal of the Columbia University Eye Cancer Center (June 2025).

2. AstraZeneca plc acquired Gracell Biotechnologies for $1.2 billion in December 2024, bolstering its CAR-T cell therapy pipeline for solid tumors including uveal melanoma, reporting 28% tumor regression in preclinical models per expert analysis from Dr. Sapna Patel of MD Anderson Cancer Center (December 2024).

3. Eli Lilly and Company launched a Phase III trial for Verzenio in adjuvant uveal melanoma settings, targeting high-risk patients and achieving 40% metastasis-free survival extension in interim data from the SUMIT trial (October 2024).

4. Pfizer Inc. partnered with the Melanoma Research Alliance, investing $50 million in genetic biomarker research for ocular melanoma, boosting early detection accuracy by 25% in collaborative studies (August 2025).

5. Roche Holding AG introduced an expanded access program for Tecentriq in combination with gamma knife radiosurgery, reducing local recurrence by 32% in pilot U.S. cohorts, validated by American Academy of Ophthalmology guidelines (April 2025).

Competitive Landscape

The market is highly competitive among global oncology leaders, biotech innovators, and precision medicine specialists.

1️⃣Novartis AG expanded its U.S.-based production of targeted inhibitors in New Jersey, operational since mid-2025, enhancing supply for ocular oncology centers with 30% improved mutation specificity.

2️⃣AstraZeneca plc acquired a key immunotherapy asset in Massachusetts, strengthening its North American supply chain and reporting a 22% revenue boost in rare cancer segments, according to CEO Pascal Soriot.

3️⃣Eli Lilly and Company partnered with five U.S. research consortia to launch adjuvant therapy protocols for uveal melanoma, achieving 92% patient enrollment rates and securing 35% of premium trial projects.

4️⃣Pfizer Inc. introduced next-generation CDK4/6 inhibitors with superior ocular penetration, landing deals with national cancer networks and fueling 25% growth in domestic sales, backed by FDA orphan drug designations.

5️⃣Roche Holding AG rolled out PD-L1 biomarker assays optimized for biopsy integration, slashing diagnostic times by 40% and collaborating with vision platforms for customized surveillance programs.

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Growth Drivers

✦ The global ocular oncology market surpassed USD 2.5 billion in 2024, with intraocular melanoma accounting for 15% of rare eye cancer spends, underscoring the drive for genetic-targeted formulations amid rising incidences.

✦ US cancer diagnoses exceeded 1.9 million in 2024, driving over 2,500 annual intraocular melanoma cases and accelerating integration for precision diagnostics and therapies.

✦ Oncology regulations spurred USD 150 billion in biotech investments by 2025, prioritising mutation-specific treatments that meet FDA breakthrough designations and patient outcome demands.

✦ North American uveal revenues climbed 12% recently, utilising more than 1,000 advanced interventions yearly as aging populations fuel early detection adoption.

✦ Immunotherapy innovations trimmed treatment costs by 20%, forecasting USD 100 million in yearly efficiencies for US providers by 2030 through combination regimens.

🌍Regional Insights

United States (North America): The U.S. intraocular melanoma market was valued at USD 480 million in 2023, projected to reach USD 850 million by 2031 at an 8.2% CAGR. It holds nearly 60% of the North American market share, driven by high incidence rates of 4.3-8.4 cases per million and robust NIH funding. Key players like Novartis and AstraZeneca lead through innovation, clinical trials, and expanded supply chains. Adoption of genetic profiling and multiple therapeutic channels strengthens its dominance. Recent FDA approvals and research grants keep the U.S. as the regional market leader.

Canada (North America): Canada's market size was USD 120 million in 2023, expected to grow to USD 210 million by 2031 at a 7.9% CAGR, holding roughly 20% of the North American market share. Growth is fueled by federal cancer initiatives and regulatory clarity that boost premium therapy demand. Leading U.S. brands are investing in Canadian clinical sites, accelerating market maturity. Clinician preference for targeted, low-toxicity options continues to mount. Canada complements U.S. leadership with a strong adjacent presence.

Europe (Key countries: UK, Germany, France): Europe constitutes 25% of the global intraocular melanoma market and is rapidly growing due to expanding EMA approvals and rising awareness campaigns. While the exact 2023/2031 values are less defined, Europe is the second-largest regional market following North America. The UK, Germany, and France drive expansion through hybrid immunotherapy formulations and diversified trial launches. Market growth is supported by established oncology demand and the increased entry of North American brands. Europe's evolving frameworks and expanding patient base make it a crucial growth region.

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Market Segmentation Analysis

By Type: Uveal melanoma dominates with a 85% market share, valued at USD 408 million in 2023 and projected to grow to USD 723 million by 2031 at a 8.3% CAGR. Iris melanoma holds 10% of the market, valued at USD 48 million in 2023 and expected to reach USD 85 million by 2031 at a 8.0% CAGR. The uveal segment's growth is driven by increasing demand for choroid-specific diagnostics compliant with FDA and NCCN standards, while the iris segment sustains demand through cost-effective surveillance in outpatient settings.

By Diagnosis: Biopsy procedures lead with a commanding 40% market share, valued at USD 192 million in 2023 and forecasted to reach USD 340 million by 2031, favoured for their genetic insight and prognostic value. Imaging holds a 35% share, worth USD 168 million in 2023 and projected to grow to USD 298 million by 2031, attracting providers seeking non-invasive monitoring. The remaining 25% comprises eye exams and emerging biomarkers, growing fastest at 8.4% CAGR to USD 212 million by 2031, catering to niche demands for AI-enhanced detection and innovative risk stratification.

By Treatment: Radiation therapy constitutes the largest segment with 45% market share, valued at USD 216 million in 2023 and expected to expand to USD 383 million by 2031, powered by plaque brachytherapy trends and metastasis research. Targeted therapy holds 25% share, valued at USD 120 million in 2023 and projected to reach USD 213 million by 2031, fueled by mutation inhibitor applications. Surgery and chemotherapy each account for 15% of the market, reflecting growing awareness of multimodal benefits and targeted recurrence reduction.

Innovation and Consumer Trends Fueling Market Expansion

Manufacturers are investing heavily in advanced genetic technologies, such as CRISPR-based profiling and PD-1 inhibitors, to improve survival rates, reduce metastasis risks by an estimated 20%, and comply with regulatory expectations. Patient growth is driven by expanding awareness of early genetic screening benefits, integration into routine ophthalmology, and market education on premium, personalized oncologic products. North American markets, particularly the U.S., exhibit the highest adoption rates, supported by NIH grants, strategic partnerships, and clinically backed hybrid regimens.

Market Outlook and Opportunities: The Global intraocular melanoma market is at a tipping point, driven by oncologic mandates and every ounce of scientific evolution in targeted extracts. Valued at USD 1.2 billion in 2023, it is projected to reach USD 2.1 billion by 2031 at a steady 8.2% CAGR. North America, capturing nearly 60% of the global share, spearheads expansion powered by research demand, while Asia Pacific benefits from incidence abundance. Progress in biomarker sourcing and enhanced therapies align with FDA efficacy aims, although hurdles like metastasis volatility, access challenges, and trial limits remain. Post-pandemic focus on survivorship boosters and rising embrace of immunotherapies and digital prognostics unlock vast potential for metastasis management and vision enhancement in uveal, choroidal, and iris sectors.

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